Effect of Dipeptidyl Peptidase-IV Inhibitor and Sulfonylurea on Glucose Variability and Oxidative Stress

Type 2 Diabetes Clinical Trial

Official title:

The Comparative Study of Dipeptidyl Peptidase-IV Inhibitor and Sulfonylurea on the Effect of Improving Glucose Variability and Oxidative Stress in Type 2 Diabetic Patients With Inadequate Glycemic Control on Metformin

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00699322
• Other study ID #: KCMC08MI081
• Status: Unknown status
• Phase: Phase 4
• First received: June 16, 2008
• Last updated: October 28, 2009
• Start date: June 2008
• Est. completion date: June 2010

Study information

• Verified date: October 2009
• Source: The Catholic University of Korea
• Contact: Kun-Ho Yoon, M.D., Ph.D.
• Phone: 82-2-590-1402
• Email: yoonk[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research will focus on the effect of Sitagliptin on 24 hour glycemic excursion and improvement of oxidative stress markers compared to long acting sulphonylurea Glimepiride in type 2 diabetic patients with inadequate glycemic control on metformin

Description:

Sitagliptin might improve not only the mean glycemic control during study period but also 24 hour glycemic fluctuation by restoring the physiologic pattern of insulin secretion. Furthermore decrease postprandial glycemic excursion should decrease the oxidative stress markers. Those effects might be amplified in Asian patients because of prominent early phase insulin secretory defects accompanied with relatively less degree of insulin resistance. Based on this assumption, this research will focus on the effect of Sitagliptin on 24 hour glycemic excursion and improvement of oxidative stress markers compared to long acting sulphonylurea Glimepiride in type 2 diabetic patients with inadequate glycemic control on metformin.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 36
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients with type 2 diabetes

• duration of diabetes less than 10 years

• HbA1c 6.5-8.0%

• BMI 20-30

• on stable dose of metformin (more than 1000mg) for at least 2 months

Exclusion Criteria:

• having oral hypoglycemic agents other than metformin

• using insulin

• serum creatinin >= 1.5 mg/dL

• SGOT, SGPT >= 90

• ischemic heart disease

• congestive heart failure (NYHA class >=2)

• severe diabetic complication (PDR, CRF, CVA)

• on medication affecting glucose profile (such as steroid)

• infectious disease

• malignancy

• pregnant or breast-feeding woman

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• Sitagliptin
100mg P.O. per day for 1month
• Glimepiride
2mg P.O. per day for 1 month

Locations

Country	Name	City	State
Korea, Republic of	Kangnam St. Mary's hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
The Catholic University of Korea	MSD Korea Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Colette C, Monnier L. Acute glucose fluctuations and chronic sustained hyperglycemia as risk factors for cardiovascular diseases in patients with type 2 diabetes. Horm Metab Res. 2007 Sep;39(9):683-6. Review. — View Citation

Monnier L, Mas E, Ginet C, Michel F, Villon L, Cristol JP, Colette C. Activation of oxidative stress by acute glucose fluctuations compared with sustained chronic hyperglycemia in patients with type 2 diabetes. JAMA. 2006 Apr 12;295(14):1681-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose variability		1 month
Secondary	oxidative stress markers (oxidized LDL, N-carboxymethyl-lysine(CML), nitrotyrosine, 8-iso-prostaglandinF2a, 8-OhDG)		1 month